Prodol
Generic Name
Tramadol Hydrochloride + Paracetamol
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| prodol 325 mg tablet | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Prodol 325 mg Tablet is a combination pain reliever containing Tramadol and Paracetamol, used to treat moderate to moderately severe pain.
Uses & Indications
Dosage
Adults
Adults (16 years and older): 1-2 tablets every 4-6 hours as needed, not to exceed 8 tablets (300 mg Tramadol / 2600 mg Paracetamol) per day.
Elderly
For elderly patients (over 75 years), dosage adjustments may be necessary due to potential for reduced renal/hepatic function. Initial dose typically 1 tablet every 6 hours, not exceeding 6 tablets per day.
Renal_impairment
Not recommended for severe renal impairment (creatinine clearance <10 mL/min). For moderate impairment (creatinine clearance 10-30 mL/min), extend dosing interval to 12 hours. Consult a physician for specific recommendations.
How to Take
Take orally with a glass of water, with or without food. Do not crush, chew, or break the tablet.
Mechanism of Action
Tramadol acts centrally as an opioid agonist, inhibiting norepinephrine and serotonin reuptake. Paracetamol is a non-opioid analgesic and antipyretic, thought to act by inhibiting prostaglandin synthesis in the CNS.
Pharmacokinetics
Onset
Analgesic effect typically begins within 30-60 minutes after oral administration.
Excretion
Both tramadol and its metabolites, as well as paracetamol and its metabolites, are primarily excreted renally (via urine).
Half life
Tramadol's elimination half-life is approximately 5-7 hours; Paracetamol's elimination half-life is about 2-3 hours.
Absorption
Both tramadol and paracetamol are well absorbed orally. Peak plasma levels for tramadol are reached in approximately 2-3 hours, and for paracetamol in about 1 hour.
Metabolism
Tramadol is metabolized by CYP2D6 to O-desmethyltramadol (an active metabolite) and by CYP3A4. Paracetamol is primarily metabolized in the liver via glucuronidation and sulfation.
Side Effects
Contraindications
- Hypersensitivity to tramadol, paracetamol, or any component of the formulation.
- Acute intoxication with alcohol, hypnotics, opioids, or psychotropic drugs.
- Severe respiratory depression.
- Severe hepatic impairment.
- Epilepsy not controlled by adequate treatment.
- Concurrent use with monoamine oxidase (MAO) inhibitors or within 14 days of discontinuing them.
Drug Interactions
Carbamazepine
Significantly reduces plasma concentrations of tramadol, leading to reduced analgesic effect.
MAO Inhibitors
Concurrent use or within 14 days of MAOI discontinuation may lead to serotonin syndrome or seizures.
Warfarin and coumarin derivatives
May increase INR and risk of bleeding.
Serotonergic drugs (e.g., SSRIs, SNRIs, triptans)
Increased risk of serotonin syndrome.
CNS Depressants (e.g., alcohol, sedatives, hypnotics, other opioids)
Increased risk of CNS depression, respiratory depression, hypotension, and profound sedation.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include respiratory depression, seizures, somnolence, coma, cold and clammy skin, miosis, and hypotension. Paracetamol overdose can lead to hepatic necrosis. Management involves supportive care, naloxone for opioid effects, and N-acetylcysteine for paracetamol toxicity.
Pregnancy & Lactation
Not recommended during pregnancy due to potential for neonatal opioid withdrawal syndrome. Avoid during breastfeeding as both tramadol and its active metabolite are excreted in breast milk and may cause adverse effects in the infant.
Side Effects
Contraindications
- Hypersensitivity to tramadol, paracetamol, or any component of the formulation.
- Acute intoxication with alcohol, hypnotics, opioids, or psychotropic drugs.
- Severe respiratory depression.
- Severe hepatic impairment.
- Epilepsy not controlled by adequate treatment.
- Concurrent use with monoamine oxidase (MAO) inhibitors or within 14 days of discontinuing them.
Drug Interactions
Carbamazepine
Significantly reduces plasma concentrations of tramadol, leading to reduced analgesic effect.
MAO Inhibitors
Concurrent use or within 14 days of MAOI discontinuation may lead to serotonin syndrome or seizures.
Warfarin and coumarin derivatives
May increase INR and risk of bleeding.
Serotonergic drugs (e.g., SSRIs, SNRIs, triptans)
Increased risk of serotonin syndrome.
CNS Depressants (e.g., alcohol, sedatives, hypnotics, other opioids)
Increased risk of CNS depression, respiratory depression, hypotension, and profound sedation.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include respiratory depression, seizures, somnolence, coma, cold and clammy skin, miosis, and hypotension. Paracetamol overdose can lead to hepatic necrosis. Management involves supportive care, naloxone for opioid effects, and N-acetylcysteine for paracetamol toxicity.
Pregnancy & Lactation
Not recommended during pregnancy due to potential for neonatal opioid withdrawal syndrome. Avoid during breastfeeding as both tramadol and its active metabolite are excreted in breast milk and may cause adverse effects in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory authorities
Patent Status
Off-patent
Clinical Trials
Combination tramadol and paracetamol has been extensively studied for its efficacy and safety in various pain conditions. Ongoing studies continue to assess long-term outcomes and specific population effects.
Lab Monitoring
- Liver function tests (especially with chronic use or in patients with pre-existing hepatic impairment).
- Renal function tests (in patients with renal impairment, especially elderly).
Doctor Notes
- Assess patient for risk factors of opioid abuse, addiction, and misuse before initiating treatment.
- Educate patients and caregivers on how to recognize and respond to overdose, including naloxone administration if prescribed.
- Consider dosage adjustment in elderly patients and those with renal or hepatic impairment.
- Monitor for signs of serotonin syndrome, especially if co-administered with other serotonergic drugs.
Patient Guidelines
- Do not exceed the recommended dose to avoid potential liver damage from paracetamol and risks associated with tramadol.
- Avoid alcohol while taking this medicine.
- Inform your doctor about all other medications, herbal products, and supplements you are taking.
- Do not stop taking this medicine abruptly without consulting your doctor, as withdrawal symptoms may occur.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness, drowsiness, or blurred vision. Patients should be advised to avoid driving or operating machinery until they are certain that Prodol 325 mg Tablet does not adversely affect their ability to perform such activities.
Lifestyle Advice
- Avoid driving or operating heavy machinery until you know how this medicine affects you, as it may cause dizziness or drowsiness.
- Keep this medicine out of reach of children and pets.
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